Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer

Phase 1

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: INCB007839 300mg BID; Drug: Trastuzumab; Drug: Vinorelbine

• Registration Number: NCT01254136
• Lead Sponsor: Incyte Corporation

Brief Summary

This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-06
• Disposition First Submitted: 2010-12-13
• Disposition First Submitted QC: 2010-12-13
• Disposition First Posted: 2010-12-16
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-20
• Last Update Posted: 2012-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
• Subject with histological HER2+ status as determined by FISH with a gene amplification score of ≥ 2.2
• Subject with availability of archival biopsy tissue from primary tumor or metastatic lesions
• Subject with presence of measurable disease based on RECIST 1.1
• Subject who has received no more than three prior HER2-directed therapeutic regimens for advanced breast cancer

Exclusion Criteria

• Subject with Left ventricular ejection fraction (LVEF) below institutional normal range
• Subject with metastasis to the central nervous system UNLESS asymptomatic and clinically stable
• Subject with current active malignancy other than breast cancer
• Subject with prior history of other malignancy except for cancers from which the patient is currently disease free
• Subject with significant renal or hepatic dysfunction
• Subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy
• Subject with insufficient bone marrow function
• Subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy.
• Subject with current active bacterial, Hepatitis B or C, and/or HIV infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment A - INCB007839 300mg BID	INCB007839 300mg BID	This is a single arm, open label study in which all patients will receive a single dose of the investigational product INCB007839 in combination with a standard regimen of trastuzumab and vinorelbine.
Treatment A - INCB007839 300mg BID	Vinorelbine	This is a single arm, open label study in which all patients will receive a single dose of the investigational product INCB007839 in combination with a standard regimen of trastuzumab and vinorelbine.
Treatment A - INCB007839 300mg BID	Trastuzumab	This is a single arm, open label study in which all patients will receive a single dose of the investigational product INCB007839 in combination with a standard regimen of trastuzumab and vinorelbine.

Primary Outcome Measures

Name	Time	Method
Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations.	Measured monthly starting at Baseline (estimated duration 6-9 months)

Secondary Outcome Measures

Name	Time	Method
Overall objective response rate assessed by RECIST criteria	Measured at Baseline, Cycle 4 and approximately every 9 weeks after (estimated duration 6-9 months)